FDA Webview

Free FDA Notices

Guidance on Device Manufacturing Site Change Supplements


Federal Register Notice: FDA is making available a draft guidance entitled Manufacturing Site Change Supplements: Content and Submission. The document describes the decision-making steps that FDA recommends to determine whether a PMA supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. To download this draft guidance, click here. To view this notice, click here.